Chemical Pathology Analytical Performance Specifications


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Analyte Lower limit Upper limit Basis Level
Alcohol + or - 2.0 ≤ 20.0mmol/L + or - 10% > 20.0 mmol/L Prof. Opinion
Ammonia + or - 5 ≤ 50 umol/L/L + or - 10% > 50 umol/L/L Prof. Opinion
Analyte Lower limit Upper limit Basis Level
Itraconazole + or - 0.1 ≤ 1.0 mg/L + or - 10% > 1.0 mg/L Prof. Opinion
Fluconazole + or - 2.0 ≤ 20.0 mg/L + or - 10% > 20.0 mg/L Prof. Opinion
Hydroxyitraconazole + or - 0.2 ≤ 2.0 mg/L + or - 10% > 2.0 mg/L Prof. Opinion
Posaconazole + or - 0.1 ≤ 1.0 mg/L + or - 10% > 1.0 mg/L Prof. Opinion
Voriconazole + or - 0.2 ≤ 2.0 mg/L + or - 10% > 2.0 mg/L Prof. Opinion
Flucytosine + or - 10 ≤ 100 mg/L + or - 10% > 100 mg/L Prof. Opinion
Analyte Lower limit Upper limit Basis Level
Amikacin + or - 2.0 ≤ 19.9 mg/L + or - 10% > 19.9 mg/L Prof. Opinion
Gentamicin + or - 0.2 ≤ 2.0 mg/L + or - 10% > 2.0 mg/L Prof. Opinion
Tobramycin + or - 0.2 ≤ 2.0 mg/L + or - 10% > 2.0 mg/L Prof. Opinion
Vancomycin + or - 2.0 ≤ 20.3 mg/L + or - 10% > 20.3 mg/L Prof. Opinion
Analyte Lower limit Upper limit Basis Level
Total Bile Acids + or - 4 ≤ 40 umol/L + or - 10% > 40 umol/L Prof. Opinion
Analyte Lower limit Upper limit Basis Level
Adrenaline + or - 30 ≤ 100 nmol/L + or - 30% > 100 nmol/L Total Error Optimal
Dopamine + or - 0.20 ≤ 2.0 µmol/L + or - 10% > 2.0 µmol/L Imprecision Optimal
5HIAA + or - 8 ≤ 40 µmol/L + or - 20% > 40 µmol/L Imprecision Desirable
HMMA + or - 6 ≤ 40 µmol/L + or - 15% > 40 µmol/L Total Error Optimal
HVA + or - 6 ≤ 40 µmol/L + or - 15% > 40 µmol/L Imprecision Desirable
Metanephrine + or - 0.2 ≤ 1.0 µmol/L + or - 20% > 1.0 µmol/L Total Error Optimal
Noradrenaline + or - 75 ≤ 500 nmol/L + or - 15% > 500 nmol/L Total Error Optimal
Normetanephrine + or - 0.4 ≤ 2.0 µmol/L + or - 20% > 2.0 µmol/L Total Error Optimal
3-Methoxytyramine + or - 0.3 ≤ 2.0 µmol/L + or - 15% > 2.0 µmol/L Total Error Optimal
Serotonin + or - 0.2 ≤ 1.0 µmol/L + or - 20% > 1.0 µmol/L Prof. Opinion
Analyte Lower limit Upper limit Basis Level
Chloride + or - 3 ≤ 100 mmol/L + or - 3% > 100 mmol/L Total Error Minimal
Glucose + or - 0.4 ≤ 5.0 mmol/L + or - 8% > 5.0 mmol/L Imprecision Desirable
Ionised Calcium + or - 0.04 ≤ 1.00 mmol/L + or - 4% >1.00 mmol/L Total Error Minimal
Lactate + or - 0.5 ≤ 4.0 mmol/L + or - 12% > 4.0 mmol/L Imprecision Optimal
pH + or - 0.04 + or - 0.04 Prof. Opinion
pCO2 + or - 2.0 ≤ 34.0 mm Hg + or - 6% > 34.0 mm Hg Total Error Desirable
pO2 +/- 5 to 83 mm Hg + or - 6% > 83 mm Hg Prof. Opinion Desirable
Potassium + or - 0.2 ≤ 4.0 mmol/L + or - 5% > 4.0 mmol/L Imprecision Desirable
Sodium + or - 3 ≤ 150 mmol/L + or - 2% > 150 mmol/L Total Error Minimal
Urea + or - 0.5 ≤ 4.0 mmol/L + or - 12% > 4.0 mmol/L Imprecision Desirable
Creatinine + or - 8.0 ≤ 100.0 µmol/L + or - 8% > 100.0 µmol/L Imprecision Minimal
Analyte Lower limit Upper limit Basis Level
NT-Pro-BNP + or - 25 ≤ 125 ng/L + or - 20% > 125 ng/L Total Error Optimal
BNP + or - 20 ≤ 100 ng/L + or - 20% > 100 ng/L Prof. Opinion
Analyte Lower limit Upper limit Basis Level
Albumin + or - 2.0 ≤ 33.0 g/L + or - 6% > 33.0 g/L
Amylase + or - 20 ≤ 100 U/L + or - 20% > 100 U/L
Cholesterol + or - 0.3 ≤ 2.5 mmol/L + or - 12% > 2.5 mmol/L
Creatinine + or - 16 ≤ 100 umol/L + or - 16% > 100 umol/L
Glucose + or - 0.4 ≤ 5.0 mmol/L + or - 8% > 5.0 mmol/L
Lactate + or - 1.0 ≤ 4.0 mmol/L + or - 25% > 4.0 mmol/L
Lactate Dehydrogenase (L->P) + or - 20 ≤ 250 U/L + or - 8% > 250 U/L
Lipase + or - 24 ≤ 60 U/L + or - 40% > 60 U/L
Osmolality + or - 8 ≤ 266 mmol/kg + or - 3% > 266 mmol/kg
pH + or - 0.2 + or - 0.2
Potassium + or - 0.4 ≤ 4.0 mmol/L + or - 10% > 4.0 mmol/L
Protein + or - 3.0 ≤ 60.0 g/L + or - 5% > 60.0 g/L
Sodium + or - 6 ≤ 150 mmol/L + or - 4% > 150 mmol/L
Triglycerides + or - 0.3 ≤ 1.2 mmol/L + or - 25% > 1.2 mmol/L
Urate + or - 0.060 ≤ 0.380 mmol/L + or - 16% > 0.380 mmol/L
Urea + or - 1.0 ≤ 4.0 mmol/L + or - 24% > 4.0 mmol/L
CA 19-9 + or - 12 ≤ 40 kU/L + or - 30% > 40 kU/L
CEA + or - 1.2 ≤ 5.0 ug/L + or - 24% > 5.0 ug/L
Analyte Lower limit Upper limit Basis Level
Calprotectin - Quant + or -10 ≤50 µg/g + or - 20% >50 µg/g Prof. Opinion
Elastase - Quant + or -15 ≤100 µg/ + or - 20% >100 µg/g Prof. Opinion
Analyte Lower limit Upper limit Basis Level
Haemoglobin Concentration + or - 5 ≤ 100 g/L + or - 5% > 100 g/L Total Error Desirable
Fractional Oxyhaemoglobin + or - 3 ≤ 75.0% + or - 4% > 75.0% Prof. Opinion
Fractional Carboxyhaemoglobin + or - 1.0 ≤ 5.0% + or - 20% > 5.0% Prof. Opinion
Fractional Methaemoglobin + or - 2.0 ≤ 20% + or - 10% > 20% Prof. Opinion
Analyte Lower limit Upper limit Basis Level
CRP + or - 0.8 ≤ 4.0 mg/L + or - 20% > 4.0 mg/L
Analyte Lower limit Upper limit Basis Level
Albumin + or - 0.02 ≤ 0.1 g/L + or - 20% > 0.1 g/L Prof. Opinion
Glucose + or - 0.2 ≤ 2.0 mmol/L + or - 10% > 2.0 mmol/L Prof. Opinion
Immunoglobulin G + or - 0.02 ≤ 0.10 g/L + or - 20% > 0.10 g/L Prof. Opinion
Lactate + or - 0.3 ≤ 3.0 mmol/L + or - 10% > 3.0 mmol/L Prof. Opinion
Total Protein + or - 0.05 ≤ 0.50 g/L + or - 10% > 0.50 g/L Prof. Opinion
Bilirubin Concentration + or - 0.12 ≤ 0.60 µmol/L + or - 20% > 0.60 µmol/L Prof. Opinion
Xanthochromia – Bilirubin screen + or - 0.002 ≤ 0.007 AU + or - 20% > 0.007 AU Prof. Opinion
Xanthochromia – Haemoglobin screen + or - 0.02 ≤ 0.100 AU + or - 20% > 0.100 AU Prof. Opinion
Analyte Lower limit Upper limit Basis Level
AFP + or - 2 ≤ 17 kIU/L + or -12% > 17 kIU/L Imprecision Desirable
Aldosterone + or - 24 ≤ 160 pmol/L + or - 15% > 160 pmol/L Imprecision Optimal
Androstenedione + or - 1.5 ≤ 10 nmol/L + or - 15% > 10 nmol/L Total Error Optimal
CA125 + or - 6 ≤ 50 kU/L + or - 12% > 50 kU/L Imprecision Optimal
CEA + or - 0.6 ≤ 5.0 µg/L + or - 12% > 5.0 µg/L Imprecision Desirable
Cortisol + or - 15 ≤ 100 nmol/L + or - 15% > 100 nmol/L Imprecision Optimal
DHEA Sulphate + or - 1.2 ≤ 10.0 µmol/L + or - 12% > 10.0 µmol/L Total Error Desirable
Ferritin + or - 4.0 ≤ 27.0 µg/L + or - 15% > 27.0 µg/L Imprecision Desirable
Folate + or - 1.5 ≤ 6.0 nmol/L + or - 25% > 6.0 nmol/L Imprecision Desirable
FSH + or - 1.0 ≤ 10.0 IU/L + or - 10% > 10.0 IU/L Imprecision Desirable
Growth Hormone + or - 1 ≤ 7 mU/L + or - 15% > 7 mU/L Imprecision Optimal
hCG + or - 1 ≤ 10 IU/L + or - 10% > 10 IU/L Prof. Opinion
Homocysteine + or - 1.5 ≤ 15.0 µmol/L + or - 10% > 15.0 µmol/L Total Error Optimal
17-Hydroxyprogesterone + or - 2.0 ≤ 10.0 nmol/L + or - 20% > 10.0 nmol/L Total Error Optimal
Insulin + or - 0.6 ≤ 5.0 mU/L + or - 12% > 5.0 mU/L Imprecision Optimal
LH + or - 1.5 ≤ 10.0 IU/L + or - 15% > 10.0 IU/L Imprecision Desirable
Oestradiol + or - 25 ≤ 100 pmol/Ll + or - 25% > 100 pmol/L Total Error Desirable
Oestriol(Unconjugated) + or - 0.9 ≤ 6.0 nmol/L + or - 15% > 6.0 nmol/L Prof. Opinion
PTH + or - 1.0 ≤ 8.0 pmol/L + or - 12% > 8.0 pmol/L Imprecision Optimal
Progesterone + or - 2 ≤ 10 nmol/L + or - 15% > 10 nmol/L Imprecision Optimal
Prolactin + or - 40 ≤ 400 mIU/L + or - 10% > 400 mIU/L Imprecision Minimal
SHBG + or - 6 ≤ 50 nmol/L + or - 12% > 50 nmol/L Imprecision Desirable
Testosterone + or - 0.4 ≤ 2.7 nmol/L + or - 15% > 2.7 nmol/L Imprecision Minimal
TSH + or - 0.10 ≤ 0.50 mU/L + or - 20% > 0.50 mU/L Imprecision Desirable
Free T3 + or - 0.7 ≤ 3.5 pmol/L + or - 20% > 3.5 pmol/L Total Error Desirable
Free T4 + or - 1.5 ≤ 12 pmol/L + or - 12% > 12 pmol/L Total Error Desirable
Total T3 + or - 0.2 ≤ 1.3 nmol/L + or - 15% > 1.3 nmol/L Total Error Desirable
Total Thyroxine + or - 12 ≤ 120 nmol/L + or - 10% > 120 nmol/L Total Error Desirable
Vitamin B12 + or - 18 ≤ 120 pmol/L + or - 15% > 120 pmol/L Imprecision Desirable
Vitamin D3 + or - 9 ≤ 60 nmol/L + or - 15 % 60 nmol/L Imprecision Minimal
Total PSA + or - 0.4 ≤ 5.0 µg/L + or - 8% > 5.0 µg/L Imprecision Optimal
Free PSA + or - 0.2 ≤ 1.4 µg/L + or - 15% > 1.4 µg/L Imprecision Optimal
ACE + or - 1.0 ≤ 10.0 U/L + or - 10% > 10.0 U/L Prof. Opinion
Red Cell Folate + or - 80 ≤ 400 nmol/L + or - 20% > 400 nmol/L Imprecision Minimal
Analyte Lower limit Upper limit Basis Level
Quantitative + or - 15 ≤ 100 ng/mL + or - 15% >100 ng/mL
Analyte Lower limit Upper limit Basis Level
Albumin + or - 2.0 ≤ 33.0 g/L + or - 6% > 33.0 g/L Total Error Desirable
Alkaline Phosphatase + or - 15 ≤ 125 U/L + or - 12% > 125 U/L Total Error Desirable
ALT + or - 5 ≤ 40 U/L + or - 12% > 40 U/L Imprecision Optimal
Amylase + or - 10 ≤ 100 U/L + or - 10% > 100 U/L Imprecision Desirable
AST + or - 5 ≤ 40 U/L + or - 12% > 40 U/L Imprecision Desirable
Bicarbonate + or - 2.0 ≤ 20.0 mmol/L + or - 10% > 20.0 mmol/L Total Error Minimal
Bilirubin-Total + or - 3 ≤ 25 µmol/L + or - 12% > 25 µmol/L Imprecision Optimal
Bilirubin Conjugated + or - 3 ≤ 15 µmol/L + or - 20% > 15 µmol/L Imprecision Optimal
Calcium + or - 0.10 ≤ 2.50 mmol/L + or - 4% > 2.50 mmol/L Imprecision Minimal
Chloride + or - 3 ≤ 100 mmol/L + or - 3% > 100 mmol/L Total Error Minimal
Cholesterol + or - 0.30 ≤ 5.00 mmol/L + or - 6% > 5.00 mmol/L Imprecision Desirable
Cholinesterase + or - 500 ≤ 5000 U/L + or - 10% > 5000 U/L Prof. Opinion
Creatine Kinase + or - 15 ≤ 125 U/L + or - 12% > 125 U/L Imprecision Optimal
CK-MB + or - 3 ≤ 15 U/L or µg/L + or - 20% > 15 U/L or µg/L Imprecision Desirable
Cortisol + or - 15 ≤ 100 nmol/L + or - 15% > 100 nmol/L Prof. Opinion
Creatinine + or - 8.0 ≤ 100.0 µmol/L + or - 8% > 100.0 µmol/L Imprecision Minimal
Ferritin + or - 4.0 ≤ 27 µg/L + or - 15% > 27 µg/L Imprecision Desirable
Fructosamine + or - 15 ≤ 250 µmol/L + or - 6% > 250 µmol/L Imprecision Minimal
Glucose + or - 0.4 ≤ 5.0 mmol/L + or - 8% > 5.0 mmol/L Imprecision Desirable
GGT + or - 5 ≤ 40 U/L + or - 12% > 40 U/L Imprecision Desirable
hCG-quantitative + or - 1.0 ≤ 10.0 IU/L + or - 10% > 10.0 IU/L Prof. Opinion
HDL Cholesterol + or - 0.10 ≤ 0.80 mmol/L + or - 12% > 0.80 mmol/L Imprecision Minimal
Icterus (Quantitative) + or 6.0 ≤ 25.0 µmol/L + or - 25% > 25.0 µmol/L
Icterus (Numeric Index) + or - 1 ≤ 10 + or - 10% > 10
Iron + or - 3.0 ≤ 25.0 µmol/L + or - 12% > 25.0 µmol/L Imprecision Optimal
Lactate Dehydrogenase + or - 20 ≤ 250 U/L + or - 8% > 250 U/L Prof. Opinion
Lactate + or - 0.5 ≤ 4.0 mmol/L + or - 12% > 4.0 mmol/L Imprecision Optimal
Lipase + or - 12 ≤ 60 U/L + or - 20% > 60 U/L Imprecision Desirable
Lithium + or - 0.20 ≤ 2.0 mmol/L + or - 10% > 2.0 mmol/L Prof. Opinion
Magnesium + or - 0.10 ≤ 1.25 mmol/L + or - 8% > 1.25 mmol/L Total Error Minimal
Osmolality + or - 8 ≤ 266 mmol/kg + or - 3% > 266 mmol/kg Total Error Minimal
Phosphate + or - 0.06 ≤ 0.75 mmol/L + or - 8% > 0.75 mmol/L Imprecision Desirable
Potassium + or - 0.2 ≤ 4.0 mmol/L + or - 5% > 4.0 mmol/L Imprecision Desirable
Protein (Total) + or - 3 ≤ 60 g/L + or - 5% >60 g/L Total Error Desirable
Sodium + or - 3 ≤ 150 mmol/L + or - 2% > 150 mmol/L Total Error Minimal
Total T3 + or - 0.2 ≤ 1.3 nmol/L + or - 15% > 1.3 nmol/L Total Error Desirable
Free T3 + or - 0.7 ≤ 3.5 pmol/L + or - 20% > 3.5 pmol/L Total Error Desirable
Free T4 + or - 1.5 ≤ 12.0 pmol/L + or - 12% > 12.0 pmol/L Total Error Desirable
TSH + or - 0.1 ≤ 0.5 mU/L + or - 20% > 0.5 mU/L Imprecision Desirable
Total T4 + or - 12 ≤ 120 nmol/L + or - 10% > 120 nmol/L Total Error Desirable
TIBC + or - 4.0 ≤ 50.0 µmol/L + or - 8% > 50.0 µmol/L Prof. Opinion
Transferrin + or - 0.20 ≤ 2.50 g/L + or - 8% > 2.50 g/L Total Error Minimal
Triglyceride + or - 0.20 ≤ 1.60 mmol/L + or - 12% > 1.60 mmol/L Imprecision Optimal
Troponin I + or - 0.002 ≤ 0.010 µg/L + or - 20% > 0.010 µg/L Prof. Opinion
Troponin T + or - 0.01 ≤ 0.050 µg/L + or - 20% > 0.050 µg/L Prof. Opinion
Urate + or - 0.030 ≤ 0.380 mmol/L + or - 8% > 0.380 mmol/L Imprecision Desirable
Urea + or - 0.5 ≤ 4.0 mmol/L + or - 12% > 4.0 mmol/L Imprecision Desirable
Analyte Lower limit Upper limit Basis Level
Carbamazepine + or - 0.5 ≤ 4.7 mg/L + or - 10% > 4.7 mg/L Prof. Opinion
Digoxin + or - 0.2 ≤ 1.6 µg/L + or - 10% > 1.6 µg/L Prof. Opinion
Gentamicin + or - 0.2 ≤ 2.0 mg/L + or - 10% > 2.0 mg/L Prof. Opinion
Paracetamol + or - 3.0 ≤ 30.0 mg/L + or - 10% > 30.0 mg/L Prof. Opinion
Phenobarbitone + or - 0.7 ≤ 7.0 mg/L + or - 10% > 7.0 mg/L Prof. Opinion
Phenytoin + or - 0.8 ≤ 7.6 mg/L + or - 10% > 7.6 mg/L Prof. Opinion
Salicylate + or - 14.0 ≤ 143.0 mg/L + or - 10% > 143.0 mg/L Prof. Opinion
Theophylline + or - 0.5 ≤ 5.4 mg/L + or - 10% > 5.4 mg/L Prof. Opinion
Valproate + or - 4.0 ≤ 36.0 mg/L + or - 10% > 36.0 mg/L Prof. Opinion
Vancomycin + or - 2.0 ≤ 20.3 mg/L + or - 10% > 20.3 mg/L Prof. Opinion
Analyte Lower limit Upper limit Basis Level
HbA1c (NGSP) (%) + or - 0.4 ≤ 6.7% + or - 6% > 6.7% Prof. Opinion
HbA1c (IFCC) (mmol/mol) + or - 4 ≤ 45 mmol/mol + or - 8% > 45 mmol/mol Prof. Opinion
Analyte Lower limit Upper limit Basis Level
IGF-1 + or - 3 ≤ 25 nmol/L + or - 12% > 25 nmol/L Imprecision Minimal
C Peptide + or - 0.15 ≤ 1.25 nmol/L + or - 12% > 1.25 nmol/L Total Error Optimal
IGFBP-3 + or - 15.0 ≤ 100 nmol/L + or - 15% > 100 nmol/L Prof. Opinion
Analyte Lower limit Upper limit Basis Level
Cyclosporin + or - 10 ≤ 100 µg/L + or - 10% > 100 µg/L Prof. Opinion
Sirolimus + or - 0.5 ≤ 5.0 µg/L + or - 10% > 5.0 µg/L Prof. Opinion
Tacrolimus + or - 0.5 ≤ 5.0 µg/L + or - 10% > 5.0 µg/L Prof. Opinion
Analyte Lower limit Upper limit Basis Level
Total Bilirubin + or - 8 ≤ 80 µmol/L + or - 10% > 80 µmol/L Imprecision Optimal
Conjugated Bilirubin + or - 3 ≤ 15 µmol/L + or - 20% >15 µmol/L Imprecision Optimal
Analyte Lower limit Upper limit Basis Level
Metanephrine + or - 75 ≤ 500 pmol/L + or - 15% > 500 pmol/L Total Error Optimal
Normetanephrine + or - 200 ≤ 1000 pmol/L + or - 20% > 1000 pmol/L Total Error Optimal
Methyoxytyramine + or - 36 ≤ 120 pmol/L + or - 30% > 120 pmol/L Total Error Desirable
Analyte Lower limit Upper limit Basis Level
Troponin I + or - 0.01 ≤ 0.05 µg/L + or - 20% > 0.05 µg/L Prof. Opinion
Troponin T (Quantitative) + or - 10 ≤ 50 ng/L + or - 20% > 50 ng/L Prof. Opinion
hCG + or - 1 ≤ 10 IU/L + or - 10% > 10 IU/L Prof. Opinion
Analyte Lower limit Upper limit Basis Level
pH + or - 0.04 + or - 0.04 Prof. Opinion
pCO2 + or - 2.0 ≤ 34.0 mm Hg + or - 6% > 34.0 mm Hg Total Error Desirable
pO2 +/- 5 to 83 mm Hg + or - 6% > 83 mm Hg Prof. Opinion Desirable
TCO2 + or - 2.0 ≤ 20.0 mmol/L + or - 10% > 20.0 mmol/L Prof. Opinion
Lactate + or - 0.5 ≤ 4.0 mmol/L + or - 12% > 4.0 mmol/L Imprecision Optimal
Sodium + or - 3 ≤ 150 mmol/L + or - 2% > 150 mmol/L Total Error Minimal
Potassium + or - 0.2 ≤ 4.0 mmol/L + or - 5% > 4.0 mmol/L Imprecision Desirable
Chloride + or - 3 ≤ 100 mmol/L + or - 3% > 100 µmol/L Total Error Minimal
Ionised Calcium + or - 0.04 ≤ 1.00 mmol/L + or - 4% >1.00 mmol/L Total Error Minimal
Glucose + or - 0.4 ≤ 5.0 mmol/L + or - 8% > 5.0 mmol/L Imprecision Desirable
Urea + or - 0.5 ≤ 4.0 mmol/L + or - 12% > 4.0 mmol/L Imprecision Desirable
Creatinine + or - 8.0 ≤ 100.0 µmol/L + or - 8% > 100.0 µmol/L Imprecision Minimal
Haematocrit + or - 4 ≤ 20% + or - 20% >20% Prof. Opinion
Haemoglobin + or - 5 ≤ 100 g/L + or - 5% > 100 g/L Prof. Opinion
Analyte Lower limit Upper limit Basis Level
Urine ALA + or - 8 ≤ 32 µmol/L + or - 25% > 32 µmol/L Prof. Opinion
Urine Porphobilinogen (Quantitative) + or - 5 ≤ 20 µmol/L + or - 25% > 20 µmol/L Prof. Opinion
Urine Total Porphyrin + or - 60 ≤ 300 nmol/L + or - 20% > 300 nmol/L Prof. Opinion
Faecal Percent Dry Weight + or - 2 ≤ 20% + or - 10% > 20% Prof. Opinion
Faecal Total Porphyrin + or - 40 ≤ 200 µmol/kg + or - 20% > 200 µmol/kg Prof. Opinion
Plasma Total Porphyrin + or - 4 ≤ 20 nmol/L + or - 20% > 20 nmol/L Prof. Opinion
RBC Total Porphyrin + or - 0.4 ≤ 2.0 µmol/Lrc + or - 20% > 2.0 µmol/Lrc Prof. Opinion
Analyte Lower limit Upper limit Basis Level
Haemolysis (Quantitative) + or - 8 ≤ 80 mg/dL + or - 10% > 80 mg/dL
Haemolysis (Numeric Index) + or - 1 ≤ 10 + or - 10% > 10
Icterus (Quantitative) + or - 6.0 ≤ 25.0 µmol/L + or - 25% > 25.0 µmol/L
Icterus (Numeric Index) + or - 1 ≤ 10 + or - 10% > 10
Lipaemia (Quantitative) + or - 26 ≤ 263 mg/dL + or - 10% > 263 mg/dL
Lipaemia (Numeric Index) + or - 1 ≤ 10 + or - 10% > 10
Analyte Lower limit Upper limit Basis Level
Cholesterol + or - 0.30 ≤ 5.00 mmol/L + or - 6% > 5.00 mmol/L Prof. Opinion
HDL Cholesterol + or - 0.1 ≤ 0.80 mmol/L + or - 12% > 0.80 mmol/L Prof. Opinion
LDL Cholesterol + or - 0.20 ≤ 2.00 mmol/L + or - 10% > 2.00 mmol/L Prof. Opinion
Triglyceride + or - 0.20 ≤ 1.60 mmol/L + or - 12% > 1.60 mmol/L Prof. Opinion
Apolipoprotein A1 + or - 0.2 ≤ 2.0 g/L + or - 10% > 2.0 g/L Prof. Opinion
Apolipoprotein B + or - 0.2 ≤ 2.0 g/L + or - 10% > 2.0 g/L Prof. Opinion
Lipoprotein(a) + or - 0.06 ≤ 0.3 g/L + or - 20% > 0.3 g/L Imprecision Desirable
Analyte Lower limit Upper limit Basis Level
Amiodarone + or - 0.1 ≤ 1.3 mg/L + or - 10% > 1.3 mg/L Prof. Opinion
Amitriptyline + or - 3.0 ≤ 28.0 µg/L + or - 10% > 28.0 µg/L Prof. Opinion
Clozapine + or - 12 ≤ 100 µg/L + or - 12% > 100 µg/L Prof. Opinion
Methotrexate + or - 0.10 ≤ 1.00 µmol/L + or - 10% > 1.00 µmol/L Prof. Opinion
Mycophenolate + or - 0.10 ≤ 1.00 mg/L + or - 10% > 1.00 mg/L Prof. Opinion
Nortriptyline + or - 3.0 ≤ 26.0 µg/L + or - 10% > 26.0 µg/L Prof. Opinion
Analyte Lower limit Upper limit Basis Level
Chloride + or - 2 ≤ 40 mmol/L + or - 5% > 40 mmol/L Imprecision
Sweat Conductivity + or - 2 ≤ 50 mmol/L + or - 5% > 50 mmol/L UK Guidelines UK Guidelines
Analyte Lower limit Upper limit Basis Level
Aluminium + or - 0.08 ≤ 0.40 µmol/L + or - 20% > 0.40 µmol/L Prof. Opinion
Chromium + or - 3 ≤ 25 nmol/L + or - 12% > 25 nmol/L Prof. Opinion
Cobalt + or - 1 ≤ 10 nmol/L + or - 10% > 10 nmol/L Prof. Opinion
Copper + or - 1.6 ≤ 20.0 µmol/L + or - 8% > 20.0 µmol/L Imprecision Minimal
Lithium + or - 0.2 ≤ 2.0 mmol/L + or - 10% > 2.0 mmol/L Prof. Opinion
Magnesium + or - 0.1 ≤ 1.25 nmol/L + or - 8% > 1.25 nmol/L Prof. Opinion
Selenium + or - 0.18 ≤ 1.50 µmol/L + or - 12% > 1.50 µmol/L Imprecision Desirable
Thallium + or - 1 ≤ 10 nmol/L + or - 10% > 10 nmol/L Prof. Opinion
Vanadium + or - 1 ≤ 10 nmol/L + or - 10% > 10nmol/L Prof. Opinion
Zinc + or - 2.0 ≤ 20.0 µmol/L + or - 10% > 20.0 µmol/L Imprecision Desirable
Analyte Lower limit Upper limit Basis Level
Arsenic (Total) + or - 50 ≤ 500 nmol/L + or - 10% > 500 nmol/L Prof. Opinion
Cadmium + or - 3 ≤ 20 nmol/L + or - 15% > 20 nmol/L Prof. Opinion
Chromium + or - 3 ≤ 25 nmol/L + or - 12% > 25 nmol/L Prof. Opinion
Cobalt + or - 2 ≤ 20 nmol/L + or - 10% > 20nmol/L Prof. Opinion
Copper + or - 0.05 ≤ 0.50 µmol/L + or - 10% > 0.50 µmol/L Prof. Opinion
Iodine + or - 80 ≤ 800 nmol/L + or - 10% > 800 nmol/L Prof. Opinion
Iron + or - 3 ≤ 25 μmol/L + or - 12% > 25 µmol/L Prof. Opinion
Lead + or - 50 ≤ 500 nmol/L + or - 10% > 500 nmol/L Prof. Opinion
Magnesium + or - 0.10 ≤ 1.25 mmol/L + or - 8% > 1.25 mmol/L Prof. Opinion
Manganese + or - 3 ≤ 25 nmol/L + or - 12% > 25 nmol/L Prof. Opinion
Mercury + or - 9 ≤ 60 nmol/L + or - 15% > 60 nmol/L Prof. Opinion
Nickel + or - 40 ≤ 400 nmol/L + or - 10% > 400 nmol/L Prof. Opinion
Selenium + or - 0.06 ≤ 0.50 µmol/L + or - 12% > 0.50 µmol/L Prof. Opinion
Thallium + or - 1 ≤ 10 nmol/L + or - 10% > 10 nmol/L Prof. Opinion
Vanadium + or - 2 ≤ 10 nmol/L + or - 10% > 10 nmol/L Prof. Opinion
Zinc + or - 2.0 ≤ 20.0 µmol/L + or - 10% > 20.0 µmol/L Prof. Opinion
Analyte Lower limit Upper limit Basis Level
Arsenic (Total) + or - 10 ≤ 100 nmol/L + or - 10% > 100 nmol/L Prof. Opinion
Cadmium + or - 3 ≤ 20 nmol/L + or - 15% > 20nmol/L Prof. Opinion
Cobalt + or - 2 ≤ 10 nmol/L + or - 10% > 10 nmol/L Prof. Opinion
Chromium + or - 3 ≤ 25 nmol/L + or - 12% > 25 nmol/L Prof. Opinion
Lead + or - 0.05 ≤ 0.50 µmol/L + or - 10% > 0.50 µmol/L Optimal Imprecision
Magnesium + or - 0.10 ≤ 1.25 mmol/L + or - 8% > 1.25 mmol/L Prof. Opinion
Manganese + or - 30 ≤ 250 nmol/L + or - 12% > 250 nmol/L Prof. Opinion
Mercury + or - 9 ≤ 60 nmol/L + or - 15% > 60 nmol/L Prof. Opinion
Selenium + or - 0.30 ≤ 2.50 µmol/L + or - 12% > 2.50 µmol/L Desirable Imprecision
Thallium + or - 2 ≤ 10 nmol/L + or - 10% > 10 nmol/L Prof. Opinion
Zinc + or - 6 ≤ 60 µmol/L + or - 10% > 60 µmol/L Desirable Imprecision
Analyte Lower limit Upper limit Basis Level
ACTH + or - 2.0 ≤ 20 pmol/L + or - 10% > 20 pmol/L Prof. Opinion
Alpha-fetoprotein + or - 2 ≤ 17 kIU/L + or - 12% > 17 kIU/L Imprecision Desirable
Calcitonin + or - 2 ≤ 20 ng/L + or - 10% > 20 ng/L Prof. Opinion
CEA + or - 0.6 ≤ 5.0 µg/L + or - 12% > 5.0 µg/L Imprecision Desirable
CA125 + or - 6 ≤ 50 kU/L + or - 12% > 50 kU/L Imprecision Optimal
CA15-3 + or - 3 ≤ 30 kU/L + or - 10% > 30 kU/L Imprecision Minimal
CA19-9 + or - 6 ≤ 40 kU/L + or - 15% > 40 kU/L Imprecision Desirable
hCG + or - 1 ≤ 10 IU/L + or - 10% > 10 IU/L Prof. Opinion
Beta-2-Microglobulin + or - 0.2 ≤ 2.0 mg/L + or - 10% > 2.0 mg/L Imprecision Minimal
NSE + or - 2.0 ≤ 20 µg/L + or - 10% > 20 µg/L Prof. Opinion
Gastrin + or - 10 ≤ 100 pmol/L + or - 10% > 100 pmol/L Prof. Opinion
Prolactin + or - 40 ≤ 400 mIU/L + or - 10% > 400 mIU/L Imprecision Minimal
Total PSA + or - 0.4 ≤ 5.0 µg/L + or - 8% > 5.0 µg/L Imprecision Optimal
Thyroglobulin + or - 0.2 ≤ 1.7 µg/L + or - 12% > 1.7 µg/L Imprecision Desirable
Analyte Lower limit Upper limit Basis Level
Albumin + or - 4.0 ≤ 20.0 mg/L + or - 20% > 20.0 mg/L Prof. Opinion
Calcium + or - 0.20 ≤ 2.0 mmol/L + or - 10% > 2.0 mmol/L Prof. Opinion
Chloride + or - 4 ≤ 40 mmol/L + or - 10% > 40 mmol/L Prof. Opinion
Cortisol + or - 30 ≤ 200nmol/L + or - 15% > 200 nmol/L Prof. Opinion
Creatinine + or - 0.5 ≤ 5.0 mmol/L + or - 10% > 5.0 mmol/L Prof. Opinion
DPD (Free) + or - 15 ≤ 80 nmol/L + or - 15% > 80 nmol/L Prof. Opinion
Free 3-Methoxytyramine + or - 15 ≤ 100 nmol/L + or - 15% > 100 nmol/L
Free Metanephrine + or - 30 ≤ 100 nmol/L + or - 30% > 100 nmol/L
Free Normetanephrine + or - 40 ≤ 200 nmol/L + or - 20% > 200 nmol/L
Glucose + or - 1.0 ≤ 10.0 mmol/L + or - 10% > 10.0 mmol/L Prof. Opinion
hCG-quantitative + or - 5 ≤ 50 IU/L + or - 10% > 50 IU/L Prof. Opinion
Magnesium + or - 0.3 ≤ 2.0 mmol/L + or - 15% > 2.0 mmol/L Prof. Opinion
N-Telopeptides + or - 80 ≤ 700 nmolBCE/L + or - 10% > 700 nmolBCE/L Prof. Opinion
Osmolality + or - 6 ≤ 300 mmol/kg + or - 2% > 300 mmol/kg Prof. Opinion
Potassium + or - 2 ≤ 20 mmol/L + or - 10% > 20 mmol/L Prof. Opinion
Phosphate + or - 3 ≤ 20 mmol/L + or - 15% > 20 mmol/L Prof. Opinion
Sodium + or - 4 ≤ 40 mmol/L + or - 10% > 40 mmol/L Prof. Opinion
Total Protein + or - 0.10 ≤ 1.00 g/L + or - 10% > 1.00 g/L Prof. Opinion
Urate + or - 0.3 ≤ 2 mmol/L + or - 15% > 2 mmol/L Prof. Opinion
Urea + or - 20 ≤ 200 mmol/L + or - 10% > 200 mmol/L Prof. Opinion
ACR + or - 0.5 ≤ 3.5 mg/mmol + or - 15% > 3.5 mg/mmol Prof. Opinion
Analyte Lower limit Upper limit Basis Level
Vitamin A + or - 0.2 ≤ 1.7 μmol/L + or - 12% > 1.7 µmol/L Imprecision Desirable
Vitamin E + or - 3 ≤ 25 μmol/L + or - 12% > 25 µmol/L Imprecision Desirable
β Carotene + or - 0.4 ≤ 2.0 μmol/L + or - 25% > 2.0 µmol/L Total Error Optimal
Total Carotenoids + or - 0.8 ≤ 4.0 µmol/L + or - 25% > 4.0 µmol/L Total Error Optimal
Vitamin B6 - Plasma (Pyridoxal Phosphate) + or - 9 ≤ 60 nmol/L + or - 15% > 60 nmol/L Total Error Optimal
Vitamin B6 – Whole Blood (Pyridoxal Phosphate) + or - 9 ≤ 60 nmol/L + or - 15% > 60 nmol/L Total Error Optimal
Vitamin B1 (Thiamine Pyrophosphate) + or - 15 ≤ 150 nmol/L + or - 10% > 150 nmol/L Imprecision Desirable
Vitamin B2 + or - 25 ≤ 250 nmol/L + or - 10% > 250 nmol/L
Vitamin C + or - 7 ≤ 35 µmol/L + or - 20% > 35 µmol/L Imprecision Desirable